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AUGS advocates for evidence-based options that enhance the choices available to members and their patients who suffer with pelvic floor disorders.

Many of you will have seen the “60 Minutes” segment investigating issues with synthetic mesh implants which they called “gynecologic mesh.” This broadcast focused primarily on a single manufacturer, and issues around the supply chain and manufacturing process. It did not distinguish between mesh for SUI and mesh for prolapse. We are concerned that the broadcast could lead many patients to believe that implants they have received are inherently defective as a result of the manufacturer, and are more likely to either dissolve and disappear or, conversely, to create permanent complications.

AUGS cannot comment on the manufacturing and regulatory decisions or processes of any manufacturer. However, AUGS has no reason to disagree with the FDA’s conclusions based on a more robust interpretation of data, that currently available mesh poses no new safety concerns. On May 15, 2018 the Boston Globe provided the following statement from FDA officials:

“The FDA takes its commitment and obligations to patient safety very seriously. After the FDA became aware that Boston Scientific changed suppliers for the polypropylene resin used in the gynecologic mesh products, we conducted an extensive investigation. The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications. We also evaluated information [data and analysis], from various sources available to the FDA including the company, regarding the polypropylene raw material, as well as the finished mesh manufactured with polypropylene resin from both sources, and we conducted inspections of Boston Scientific and two of its contract manufacturers. Further, we reviewed our adverse event reporting database and did not find any indication that the change in resin led to an increase in adverse events. As a result, the FDA concluded that the new resin does not raise new safety or effectiveness concerns. In December of last year, we asked 60 Minutes for the opportunity to review their test results and hoped they would have provided this information as soon as possible, especially if they believed this data could impact public health. They declined until after their report aired, and we still have not received this information. While we have confidence in our investigation findings, we welcome any new information that would help us better evaluate this product and protect the health of patients.”

AUGS has not changed our positions about midurethral slings or mesh-based options for patients with pelvic floor disorders, nor our support for the availability of non-mesh alternatives. [Position Statement: Mesh Midurethral Slings for Stress Urinary Incontinence] We also recommend that patients who are without signs or symptoms of mesh-related complications should not be advised to undergo surgical procedures to remove their implants. We remain concerned about the practice of surgeons accepting payment from lawyers’ offices or third-party financiers to perform mesh removal surgeries which may not be clinically indicated but are being used to bolster a legal claim.

These are highly-charged issues, and passions run high. Optimizing the care of our patients demands that we remain objective, and rely on science in assessing the role of treatment modalities.

What is urinary incontinence (UI) in women?

Urinary incontinence is the loss of bladder control, resulting in the accidental loss of urine. Some women may lose urine while running or coughing, called stress incontinence. Others may feel a strong, sudden need, or urgency, to urinate just before losing urine, called urgency incontinence. Many women experience both symptoms, called mixed incontinence, or have outside factors, such as difficulty getting to a standing position or only being able to walk slowly, that prevent them from getting to a toilet on time.

UI can be slightly bothersome or totally debilitating. For some women, the chance of embarrassment keeps them from enjoying many physical activities, including exercising. People who are inactive are more likely to be obese. Obesity increases a person’s chances of developing diabetes and other related health problems. UI can also cause emotional distress. However, UI often can be controlled.

What is the urinary tract and how does it work?

The urinary tract is the body’s drainage system for removing urine, which is composed of wastes and extra fluid. For normal urination to occur, all body parts in the urinary tract need to work together in the correct order.

Kidneys. The kidneys are two bean-shaped organs, each about the size of a fist. They are located just below the rib cage, one on each side of the spine. Every day, the kidneys filter about 120 to 150 quarts of blood to produce about 1 to 2 quarts of urine. The kidneys work around the clock; a person does not control what they do.

Ureters. Ureters are the thin tubes of muscle that carry urine from each of the kidneys to the bladder.

Bladder. The bladder, located in the pelvis between the pelvic bones, is a hollow, muscular, balloon-shaped organ that expands as it fills with urine. Although a person does not control kidney function, a person does control when the bladder empties. Bladder emptying is known as urination. The bladder stores urine until the person finds an appropriate time and place to urinate. A normal bladder acts like a reservoir and can hold 1.5 to 2 cups of urine. How often a person needs to urinate depends on how quickly the kidneys produce the urine that fills the bladder. The muscles of the bladder wall remain relaxed while the bladder fills with urine. As the bladder fills to capacity, signals sent to the brain tell a person to find a toilet soon. During urination, the bladder empties through the urethra, located at the bottom of the bladder.

Three sets of muscles work together like a dam, keeping urine in the bladder between trips to the bathroom.

The first set of muscles, called the internal sphincter, is located where the bladder neck joins the urethra and along the urethra itself. The second set of muscles, along the outside of the urethra, is the external sphincter. The third set are the pelvic floor muscles, which surround and support the urethra. The pelvic floor muscles run between the pubic bone to the tail bone.

To urinate, the brain signals the muscular bladder wall to tighten, squeezing urine out of the bladder. At the same time, the brain signals the sphincters to relax. As the sphincters relax, urine exits the bladder through the urethra.

What causes urinary incontinence in women?

Urinary incontinence in women results when the brain does not properly signal the bladder, the sphincters do not squeeze strongly enough, or both. The bladder muscle may contract too much or not enough because of a problem with the muscle itself or the nerves controlling the bladder muscle. Damage to the sphincter muscles themselves or the nerves controlling these muscles can result in poor sphincter function. These problems can range from simple to complex.

What are the types of urinary incontinence in women?

The types of UI in women include

stress incontinence

urgency incontinence

mixed incontinence

other types of incontinence

Stress Incontinence

Stress incontinence results from movements that put pressure on the bladder and cause urine leakage, such as coughing, sneezing, laughing, or physical activity. Physical changes from pregnancy and childbirth often cause stress incontinence. Weakening of pelvic floor muscles can cause the bladder to move downward, pushing the bladder slightly out of the bottom of the pelvis and making it difficult for the sphincters to squeeze tightly enough. As a result, urine can leak during moments of physical stress. Stress incontinence can also occur without the bladder moving downward if the urethra wall is weak. This type of incontinence is common in women, and a health care professional can treat the condition.

Urgency Incontinence

Urgency incontinence is the loss of urine when a woman has a strong desire, or urgency, to urinate. Involuntary bladder contractions are a common cause of urgency incontinence. Abnormal nerve signals might cause these bladder contractions.

Triggers for women with urgency incontinence include drinking a small amount of water, touching water, hearing running water, or being in a cold environment—even if for just a short while—such as reaching into the freezer at the grocery store. Anxiety or certain liquids, medications, or medical conditions can make urgency incontinence worse.

Damage to the spinal cord or brain, the bladder nerves, or the bladder muscles may cause involuntary bladder contractions. Bladder nerves and muscles can be affected by

Alzheimer’s disease—a brain disorder that affects the parts of the brain that control thought, memory, and language

injury

multiple sclerosis—a disease that damages the material that surrounds and protects nerve cells, which slows down or blocks messages between the brain and body

Parkinson’s disease—a disease in which cells that make a chemical that controls muscle movement are damaged or destroyed

stroke—a condition in which the blood supply to the brain is suddenly cut off, caused by a blockage or the bursting of a blood vessel in the brain or neck

Urgency incontinence is a key sign of overactive bladder. Overactive bladder occurs when abnormal nerves send signals to the bladder at the wrong time, causing its muscles to squeeze without enough warning time to get to the toilet.

Mixed Incontinence

Mixed incontinence is when stress and urgency incontinence occur together.

Other Types of Incontinence

Functional incontinence occurs when physical disability, external obstacles, or problems in thinking or communicating keep a person from reaching a toilet in time. For example, a woman with Alzheimer’s disease may not plan ahead for a timely trip to a toilet. A woman in a wheelchair may have difficulty getting to a toilet in time. Arthritis—pain and swelling of the joints—can make it hard for a woman to walk to the toilet quickly or unbutton her pants in time.

Transient incontinence is UI that lasts a short time. Transient incontinence is usually caused by medications or a temporary condition, such as

caffeine or alcohol consumption—consumption of caffeine or alcohol can cause rapid filling of the bladder

chronic coughing—chronic coughing can put pressure on the bladder

constipation—hard stool in the rectum can put pressure on the bladder

medication—blood pressure medications can cause increased production of urine

short-term mental impairment

short-term restricted mobility

Overflow incontinence happens when the bladder doesn’t empty properly, causing it to spill over. A health care professional can check for this problem. Weak bladder muscles or a blocked urethra can cause this type of incontinence. Nerve damage from diabetes or other diseases can lead to weak bladder muscles; tumors and urinary stones can block the urethra. Overflow incontinence is rare in women.

Functional incontinence occurs when physical disability, external obstacles, or problems in thinking or communicating keep a person from reaching a toilet in time.

How common is urinary incontinence in women?

Research shows that 25 to 45 percent of women have some degree of UI. In women ages 20 to 39, 7 to 37 percent report some degree of UI. Nine to 39 percent of women older than 60 report daily UI. Women experience UI twice as often as men.1 Pregnancy, childbirth, menopause, and the structure of the female urinary tract account for this difference.

How is urinary incontinence in women diagnosed?

Women should let their health care provider, such as a family practice physician, a nurse, an internist, a gynecologist, urologist, or a urogynecologist—a gynecology doctor who has extra training in bladder problems and pelvic problems in women—know they have UI, even if they feel embarrassed. To diagnose UI, a health care professional will take a medical history and conduct a physical exam. The health care professional may order diagnostic tests, such as a urinalysis.

Medical History

The health care professional will take a medical history and ask about symptoms, patterns of urination and urine leakage, bowel function, medications, history of childbirth, and past pelvic operations. To prepare for the visit with the health care professional, a woman may want to keep a bladder diary for several days beforehand. Information that a woman should record in a bladder diary includes

what and how much she drinks

how many times she urinates and how much urine is released

how often she has accidental leaks

whether she feels a strong urge to go before leaking

what she was doing when leaks occurred, for example, coughing or lifting

Physical Exam

The health care professional will also perform a limited physical exam to look for signs of medical conditions that may cause UI. The health care professional may order further neurologic testing if necessary. The health care professional may also perform pelvic and rectal exams.

Pelvic exam. A pelvic exam is a visual and physical exam of the pelvic organs. The health care professional has the woman come to the exam with a full bladder. The woman will sit upright with her legs spread and asks her to cough. This test is called a cough stress test. Leakage of urine indicates stress incontinence. The health care professional then has the woman lie on her back on an exam table and place her feet on the corners of the table or in supports. The health care professional looks at the pelvic organs and slides a gloved, lubricated finger into the vagina to check for prolapse or other physical problems that may be causing UI. The health care professional will determine the woman’s pelvic muscle strength by asking her to squeeze her pelvic floor muscles.

Digital rectal exam. A digital rectal exam is a physical exam of the rectum. The health care professional slides a gloved, lubricated finger into the rectum, usually during a pelvic exam. A health care professional uses the digital rectal exam to check for stool or masses in the rectum that may be causing UI.

The health care professional may diagnose the type of UI based on the medical history and physical exam or use this information to determine if a woman needs further diagnostic testing.

Diagnostic Tests

The health care professional may order one or both of the following diagnostic tests, based on the results of the medical history and physical exam:

Urinalysis. Urinalysis is testing of a urine sample. The patient collects the urine sample in a special container in a health care professional’s office or a commercial facility for testing and analysis. For the test, a nurse or technician places a strip of chemically treated paper, called a dipstick, into the urine. Patches on the dipstick change color when blood or protein is present in urine. A person does not need anesthesia for this test. The test can show if the woman has a UTI, a kidney problem, or diabetes.

Urine culture. A health care professional performs a urine culture by placing part of a urine sample in a tube or dish with a substance that encourages any bacteria present to grow. A woman collects the urine sample in a special container in a health care professional’s office or a commercial facility. The office or facility tests the sample onsite or sends it to a lab for culture. A health care professional can identify bacteria that multiply, usually in 1 to 3 days. A health care professional performs a urine culture to determine the best treatment when urinalysis indicates the woman has a UTI. More information is provided in the NIDDK health topic, Urinary Tract Infection in Adults.

Blood test. A blood test involves drawing blood at a health care professional’s office or a commercial facility and sending the sample to a lab for analysis. The blood test can show problems with kidney function or a chemical imbalance in the body.

Urodynamic testing. Urodynamic testing is any procedure that looks at how well the bladder, urethra, and sphincters store and release urine. Most urodynamic tests focus on the bladder’s ability to hold urine and empty steadily and completely. More information is provided in the NIDDK health topic, Urodynamic Testing.

How is urinary incontinence in women treated?

Treatment depends on the type of UI. Health care professionals may recommend behavioral and lifestyle changes, stopping smoking, bladder training, pelvic floor exercises, and urgency suppression as a first-line therapy for most types of UI.

Stress Incontinence

Behavioral and lifestyle changes. Women with UI may be able to reduce leaks by making behavioral and lifestyle changes. For example, the amount and type of liquid women drink can affect UI. Women should talk with their health care professional about whether to drink less liquid during the day; however, women should not limit liquids to the point of becoming dehydrated. Signs of dehydration in women include

constipation

dark-colored urine

dizziness

dry skin

fatigue, or feeling tired

less frequent urination than usual

light-headedness

thirst

A health care professional can help a woman determine how much she should drink to prevent dehydration based on her health, how active she is, and where she lives.

To decrease nighttime trips to the bathroom, women may want to stop drinking liquids several hours before bedtime if suggested by a health care professional. Limiting bladder irritants—including caffeinated drinks such as tea or coffee and carbonated beverages—may decrease leaks. Women should also limit alcoholic drinks, which can increase urine production.

Although a woman may be reluctant to engage in physical activity when she has UI, regular exercise is important for weight management and good overall health. Losing weight may improve UI and not gaining weight may prevent UI. If a woman is concerned about not having easy access to a bathroom during physical activity, she can walk indoors, like in a mall, for example. Women who are overweight should talk with their health care professional about strategies for losing weight. Being obese increases a person’s chances of developing UI and other diseases, such as diabetes. According to one study, decreasing obesity and diabetes may lessen the burden of UI, especially in women.2 More information is provided in the NIDDK health topics, Choosing a Safe and Successful Weight-loss Program and Tips to Help You Get Active.

Gastrointestinal (GI) problems, especially constipation, can make urinary tract health worse and can lead to UI. The opposite is also true: Urinary problems such as UI can make GI problems worse. For example, medications such as antimuscarinics, which health care professionals use to treat UI, have side effects such as constipation.

Health care professionals can offer several options for treating constipation. More information is provided in the NIDDK health topic, Constipation.

Although a woman may be reluctant to engage in physical activity when she has UI, regular exercise is important for weight management and good overall health.

Stopping Smoking. People who smoke should stop. Quitting smoking at any age promotes bladder health and overall health. Smoking increases a person’s chances of developing stress incontinence, as it increases coughing. Some people say smoking worsens their bladder irritation. Smoking causes most cases of bladder cancer. People who smoke for many years have a higher risk of bladder cancer than nonsmokers or those who smoke for a short time.3 People who smoke should ask for help so they do not have to try quitting alone. Call 1–800–QUITNOW (1–800–784–8669) for more information.

Bladder training. Bladder training is changing urination habits to decrease incidents of UI. Based on a woman’s bladder diary, the health care professional may suggest using the bathroom at regular timed intervals, called timed voiding. Gradually lengthening the time between trips to the bathroom can help by stretching the bladder so it can hold more urine. Recording daily bathroom habits may be helpful. More information is provided in the NIDDK health document, Daily Bladder Diary(PDF, 80 KB).

Pelvic floor muscle exercises. Pelvic floor muscle, or Kegel, exercises involve strengthening pelvic floor muscles. Strong pelvic floor muscles more effectively hold in urine than weak muscles. A woman does not need special equipment for Kegel exercises. The exercises involve tightening and relaxing the muscles that control urine flow. Pelvic floor exercises should not be performed during urination. A health care professional can help a woman learn proper technique. More information is provided in the NIDDK health topic, Kegel Exercise Tips.

Women may also learn how to perform Kegel exercises properly by using biofeedback. Biofeedback uses special sensors to measure bodily functions, such as muscle contractions that control urination. A video screen displays the measurements as graphs, and sounds indicate when the woman is using the correct muscles. The health care professional uses the information to help the woman change abnormal function of the pelvic floor muscles. At home, the woman practices to improve muscle function. The woman can perform the exercises while lying down, sitting at a desk, or standing up. Success with pelvic floor exercises depends on the cause of UI, its severity, and the woman’s ability to perform the exercises on a regular basis.

If behavioral and lifestyle changes, stopping smoking, bladder training, and pelvic floor muscle exercises are not successful, additional measures for stress incontinence, including medical devices, bulking agents, and—as a last resort—surgery, may help.

Medical devices. A health care professional may prescribe a urethral insert or pessary to treat stress incontinence. A urethral insert is a small, tamponlike, disposable device inserted into the urethra to prevent leakage. A woman may use the insert to prevent UI during a specific activity or wear it throughout the day. The woman removes the insert to urinate. A pessary is a stiff ring inserted into the vagina, where it presses against the wall of the vagina and the nearby urethra. The pressure helps reposition the urethra, leading to less leakage. The woman should remove the pessary regularly for cleaning.

Bulking agents. A doctor injects bulking agents, such as collagen and carbon beads, near the urinary sphincter to treat urgency and stress incontinence. The bulking agent makes the tissues thicker and helps close the bladder opening. Before the procedure, a health care professional may perform a skin test to make sure the woman doesn’t have an allergic reaction to the bulking agent. A doctor performs the procedure during an office visit. The woman receives local anesthesia. The doctor uses a cystoscope—a tubelike instrument used to look inside the urethra and bladder—to guide the needle for injection of the bulking agent. Over time, the body may slowly eliminate certain bulking agents, so a woman may need to have injections again. The treatment is effective in about 40 percent of cases.4

Surgery. The bladder neck dropping toward the vagina can cause incontinence problems. Surgery to treat stress incontinence includes retropubic suspension and sling procedures. A doctor performs the operations in a hospital. The patient receives general anesthesia. Most women can leave the hospital the same day, though some may need to stay overnight. Full recovery takes 2 to 3 weeks; women who also have surgery for pelvic organ prolapse at the same time may have a longer recovery time.

Retropubic suspension. With retropubic suspension, the doctor raises the bladder neck or urethra and supports it using surgical threads called sutures. The doctor makes an incision in the area between the chest and the hips—also called the abdomen—a few inches below the navel and secures the sutures to strong ligaments within the pelvis to support the urethral sphincter.

Sling. The doctor performs sling procedures through a vaginal incision and uses natural tissue, man-made sling material, or synthetic mesh tape to cradle the bladder neck or urethra, depending on the type of sling procedure being performed. The doctor attaches the sling to the pubic bone or pulls the sling through an incision behind the pubic bone or beside the vaginal opening and secures it with stitches.

The Urinary Incontinence Treatment Network compared the suspension and sling procedures and found that according to women’s bladder diaries, about 31 percent with a sling and 24 percent with a suspension were still continent, or able to hold urine, all of the time 5 years after surgery. However, 73 percent of women in the suspension group and 83 percent of women in the sling group said they were satisfied with their results. Rates of adverse events such as UTIs and UI were similar for the two groups, at 10 percent for the suspension group and 9 percent for the sling group.5

Serious complications are associated with the use of surgical mesh to repair incontinence. Possible complications include erosion through the lining of the vagina, infection, pain, urinary problems, and recurrence of incontinence.6

Each woman should speak to her health care professional to help decide which surgery, if any, is right for her.

Urgency Incontinence

Women who have urgency incontinence can use the same techniques as for stress incontinence, including bladder training, urgency suppression, pelvic floor exercises, and behavioral and lifestyle changes. A woman can also try urgency suppression techniques, medications, Botox injections, and electrical nerve stimulation if necessary.

Urgency suppression. By using certain techniques, a woman can suppress the strong urge to urinate, called urgency suppression. Urgency suppression is a way to train the bladder to maintain control so a woman does not have to panic about finding a bathroom in the meantime. Some women use distraction techniques to take their mind off the urge to urinate. Other women find taking long, relaxing breaths and being still can help. Doing pelvic floor exercises also can help suppress the urgency to urinate.

Antimuscarinics. Antimuscarinics can help relax bladder muscles and prevent bladder spasms. These medications include oxybutynin (Oxytrol), which a person can buy over the counter, tolterodine (Detrol), darifenacin (Enablex), trospium (Sanctura), fesoterodine (Toviaz), and solifenacin (VESIcare). They are available in pill, liquid, and patch form.

Botox. A doctor may use onabotulinumtoxinA (Botox), also called botulinum toxin type A, to treat urgency incontinence in women including those with neurological conditions such as spinal cord injury or multiple sclerosis. Injecting Botox into the bladder relaxes the bladder, increasing storage capacity and decreasing UI. A doctor often performs the procedure during an office visit. A woman receives local anesthesia. The doctor uses a cystoscope to guide the needle for injecting the Botox. Botox is effective for up to 10 months.7

Electrical nerve stimulation. If behavioral and lifestyle changes and medications do not improve symptoms, the health care professional may suggest electrical nerve stimulation as an option to prevent UI, urinary frequency—urinating more than normal—and other symptoms. Electrical nerve stimulation involves altering bladder reflexes using pulses of electricity. The two most common types of electrical nerve stimulation are percutaneous tibial nerve stimulation and sacral nerve stimulation.8

Percutaneous tibial nerve stimulation uses electrical stimulation of the tibial nerve, which is located in the ankle, on a weekly basis. Anesthesia is not normally needed for the procedure. In an outpatient center, a health care professional inserts a battery-operated stimulator beneath the skin near the tibial nerve. Electrical stimulation of the tibial nerve prevents bladder activity by interfering with the pathway between the bladder and the spinal cord or brain. Although percutaneous tibial nerve stimulation is considered safe, researchers continue to study the exact ways it prevents symptoms and how long the treatment can last.

Sacral nerve stimulation involves a health care professional implanting a battery-operated stimulator beneath the skin in the lower back near the sacral nerve. The procedure takes place in an outpatient center often with local anesthesia. Based on the person’s feedback, the health care professional can adjust the amount of stimulation so it works best for that individual. The electrical pulses enter the body for minutes to hours, two or more times a day, either through wires placed on the lower back or just above the pubic area—between the navel and the pubic hair—or through special devices inserted into the vagina. Sacral nerve stimulation may increase blood flow to the bladder, strengthen pelvic muscles that help control the bladder, and trigger the release of natural substances that block pain. The person can turn the stimulator on or off at any time. If a period of test stimulation is successful, a health care professional will implant a device that delivers regular impulses to the bladder. A health care professional places a wire next to the tailbone and attaches it to a permanent stimulator under the skin of the lower abdomen.

If behavioral and lifestyle changes and medications do not improve symptoms, the health care professional may suggest electrical nerve stimulation as an option to prevent UI, urinary frequency, and other symptoms.

Mixed Incontinence

Depending on the type of symptoms a woman has, she may successfully treat her mixed incontinence with techniques, medications, devices, or surgery. A health care professional can help decide what kind of treatments may work for each symptom.

Functional Incontinence

Women with functional incontinence may wear protective undergarments if they worry about reaching a toilet in time. Women who have functional incontinence should talk to their health care professional about its causes and how to prevent or treat functional incontinence.

Overflow Incontinence

A health care professional treats overflow incontinence caused by a blockage in the urinary tract with surgery to remove the obstruction. Women with overflow incontinence that is not caused by a blockage may need to use a catheter to empty the bladder. A catheter is a thin, flexible tube that is inserted through the urethra into the bladder to drain urine. A health care professional can teach a woman how to use a catheter. A woman may need to use a catheter once in a while, a few times a day, or all the time. Catheters that are used continuously drain urine from the bladder into a bag that is attached to the woman’s thigh with a strap. Women using a continuous, often called indwelling, catheter should watch for symptoms of a urinary tract infection.

Transient Incontinence

A health care professional treats transient incontinence by addressing the underlying cause. For example, if a medication is causing increased urine production leading to UI, a health care professional may try lowering the dose or prescribing a different medication. A health care professional may prescribe bacteria-fighting medications called antibiotics to treat UTIs.

How can someone cope with leaking urine?

Even after treatment, some women still leak urine from time to time. Certain products can help women cope with leaking urine:

Pads. Women can wear disposable pads in their underwear to absorb leaking urine.

Adult diapers. A woman can wear an adult diaper to keep her clothes dry.

Disposable pads. Disposable pads can be used to protect chairs and beds from urine.

Special skin cleaners and creams. Special skin cleaners and creams may help the skin around the urethra from becoming irritated. Creams can help block urine from skin.

Urine deodorizing tablets. A woman should talk with a health care professional about whether urine deodorizing tablets can make her urine smell less strongly.

Eating, Diet, and Nutrition

No direct scientific evidence links eating, diet, and nutrition to either improving or worsening UI. However, many people find that alcohol, tomatoes, spices, chocolate, caffeinated and citrus beverages, and high-acid foods may contribute to bladder irritation and inflammation, which can sometimes lead to UI.9 Moreover, good eating, diet, and nutrition are directly related to preventing factors that increase the chances of developing UI, such as obesity and diabetes.

Points to Remember

Urinary incontinence (UI) is the loss of bladder control, resulting in the accidental loss of urine.

The urinary tract is the body’s drainage system for removing urine, which is composed of wastes and extra fluid.

Every day, the kidneys filter about 120 to 150 quarts of blood to produce about 1 to 2 quarts of urine.

To urinate, the brain signals the muscular bladder wall to tighten, squeezing urine out of the bladder. At the same time, the brain signals the sphincter muscles to relax. As the sphincters relax, urine exits the bladder through the urethra.

UI in women results when the brain does not properly signal the bladder, the sphincters do not squeeze strongly enough, or both.

Stress incontinence results from movements that put pressure on the bladder and cause urine leakage, such as coughing, sneezing, laughing, or physical activity.

Physical changes from pregnancy and childbirth often cause stress incontinence.

Urgency incontinence is the loss of urine when a woman has a strong desire, or urgency, to urinate.

[3] National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services. What You Need to Know About Bladder Cancer. Rockville, MD: National Cancer Institute; 2010. NIH Publication No.10-1559.

Dr. Croak was accepted into the Society of Gynecologic Surgeons and will be inducted Spring of 2014 at the Annual Meeting in Scottsdale, Arizona. The application process involves a year long review of Dr. Croak’s surgical logs, presentation of a surgical topic or research, and recommendation by peers on the national level. Dr. Croak is the only current member of SGS in the Northwest Ohio area.

The Society of Gynecologic Surgeons is recognized as a select member group of over 250 physicians representing both private practice and academic faculty–all involved in teaching and the practice of advanced gynecologic surgery. Scientific Meetings are held annually with presentations and discussions of papers based on research in anatomy, physiology, pathology, surgical technique, or clinical results of gynecologic surgery by members and invited guests. A portion of the papers presented at the annual meetings are selected to be published in The American Journal of Obstetrics and Gynecology.

The mission of the Society of Gynecologic Surgeons is to promote excellence in gynecologic surgery through acquisition of knowledge and improvement of skills, advancement of basic and clinical research, and professional and public education.

Our office provides comprehensive lower intestinal diagnostics and services to the community. Your physician will decide when this testing is right for you.

WHAT IS ANAL ULTRASONOGRAPHY? Anal ultrasound is a non-surgical diagnostic tool used to provide information on the continence muscles of the anorectum. A specialized probe allows for visualization of these muscles through the use of a non-painful non-radiating probe. This procedure offers valuable information on the integrity of the muscles and aids in forming a treatment plan.

WHAT IS ARM? AnoRectal Manometry (ARM) is a non-surgical diagnostic tool used to provide information about the pressure and function of the rectum and anal sphincter. These muscles ring the anal canal and control bowel movements by relaxing and contracting. A specialized catheter allows for the measurement of the pressure exerted by the sphincter muscles. This procedure is not painful and offers your physician valuable information to aid in forming a treatment plan.

PURPOSE: Anal ultrasound and ARM helps diagnose the cause of chronic constipation, fecal incontinence, or incontinence of gas which may be due to:

Rectal/Anal Trauma

Weakness due to chronic over-distention

Systemic disease such as diabetes which may affect sensation

Pelvic Trauma

HOW IT WORKS: A blunt ultrasound probe no wider than your thumb is inserted into the rectum. A series of rest/squeeze/and defecatory maneuvers are done to assess the anorectal muscles. For ARM, a thin catheter is inserted through the anus and into the rectal canal. The catheter is narrower than a drinking straw so it will cause little, if any, discomfort. This specialized catheter measures pressure from many directions at the same time.

TEST PROCEDURE: You will be asked to lie on your side with knees bent. The doctor examines your rectum with a gloved finger. The ultrasound probe is inserted to take pictures of the anorectal muscles during different maneuvers. For ARM, the manometry catheter, a thin tube of soft plastic with a balloon at the tip, is inserted into your rectum. This catheter transmits the pressure recordings to a computerized testing system. At times during the test, the catheter may be slowly moved from one position to another. You will be asked to squeeze the anus as forcefully as possible or to keep these muscles completely relaxed. The balloon at the tip of the probe will be inflated. You should report when you have a sensation that your rectum is full and when you feel an urge to defecate. You may be asked to expel the balloon as you would a bowel movement.

AFTER THE TEST: You are free to return to previous activities.

HOW TO MAKE AN APPOINTMENT AND WHAT TO EXPECT:

You will be asked to purchase 1 Fleets Enema and complete it the night before the testing.

Stick to a soft diet the day of your test (applesauce, yogurt, broth)

Plan to stay about an hour for your appointment. This will include pre- and post-test meetings with the physician.

It is a good idea to wear comfortable clothing as you will need to remove clothing below the waist. If you use pads or absorbent products, please bring a replacement with you.

If you have any additional questions, please call your physician’s office.

You may be asked to keep a record of your bowel habits as well as fluid and diet intake to show to the physician.

Bring a list of medications, as these may have an effect on the bowels and bowel movements.

Dr. Croak has been named as the Director for Robotic Urogynecologic Surgery at Mercy St. Vincent’s Medical Center in Toledo, Ohio. He will be part of the Mercy robotic surgery center which has acquired its third robot and is the only one in the region with Si double console technology. Mercy St. Vincent’s recently achieved status as a national case observation site for urogynecology, one of only two in the nation.

U.S. News and World Report recently awarded St. Luke’s Hospital as a preferred top 100 hospital in the United States for gynecologic services through 2011. St. Luke’s has received this recognition since 2007 for outstanding inpatient and outpatient gynecologic services based on patient satisfaction, level of care, complexity of cases, and low complications. Dr. Croak operates at St. Luke’s Hosiptal and has been instrumental in St. Luke’s achieving this designation.

Dr. Croak has received the Patient’s Choice Award from MDx Inc for the past 5 consecutive years. This is a national clearinghouse that provides consumer ratings on physicians for websited such as vital.com or ucomparehealth.com. Dr. Croak received a 4 star highest rating.

Dr. Croak was awarded the Most Compassionate Doctor Award from the same patient rating institution for the same 5 year period.

As a gynecology practice, the Northwest Ohio Center for Urogynecology and Women’s Health, often prescribes medicines that have an important place in the prevention and treatment of conditions such as heavy or painful periods, menopausal symptoms, or osteoporosis. Medicinal therapies in the form of oral contraceptives, hormone replacement therapy, the IUD, or bone loss prevention medicines are used to significantly help women with the above problems with great successes.

As with any medicine, there is sometimes a risk to benefit ratio regarding side effects or particular dangers of the particular medicine versus the good it does that each healthcare provider should weigh with the patient being counseled. Risks with contraceptive pills or patches most often revolve around blood clots or venous thromboembolism (VTE). Most legitimate studies put that risk at 1 in 10,000 for both contraceptives and hormone replacement. Some forms of contraceptive therapy (Yazmin, Ortho-Evra) may have chemical structures that are minutely more predisposed to clot formation. In regards to the IUD, most risk is regarding insertional perforation or trauma to the uterus which is exceedingly rare according to most studies and can occur to no greater degree than with endometrial biopsy or office hysteroscopy. When talking of bisphosphonates (Fosamax) for osteoporosis, risks are mainly pointed at gastrointestinal complications like ulcers or an extremely rare condition called osteonecrosis of the jaw. Most patients who suffered these complications had histories of GI disorders or a bone cancer respectively.

The FDA, doing its due diligence, requires that pharmaceutical companies discuss these risks through a “black box” warning to inform the consumer. Unfortunately, even though these medicinal therapies have extremely positive value, a small number of people will have untoward effects as a result of these medicines. Subsequently, class-action litigation has been filed in regards to these products. Obviously, these products show continued safety overall, otherwise they would have been taken off the market. Regardless, it is up to you as the patient to discuss concerns with your healthcare provider regarding your risks and benefits when being considered a candidate for a prescription of these medicines. Please be prepared to sign or give consent stating that you have discussed the risks and benefits of the medicine before taking it and that the choice to take it is yours.

With the commencement of class action litigation in regards to robotic surgery, this document is being provided to inform you, as a patient, on FDA approval of robotic surgery for gynecologic indications. Most of this document is based on the Women’s Health and Education Center Practice Bulletin and Clinical Management Guidelines for healthcare providers, published November 23, 2009. Dr. Croak agrees and complies fully with these guidelines. He was one of the first gynecologic surgeons to learn robotic surgery and has successfully completed over 400 procedures with less than 1% complication rates for bladder/bowel/vascular injury, abdominal conversion, reoperation, or fistula. Dr. Croak is involved on the local and national level in establishing robotic safety guidelines and standards for the teaching and credentialing of residents, fellows, and surgeons.

Minimally invasive surgical techniques for performing hysterectomies and other gynecologic surgeries have been shown to reduce patient morbidity and shorten hospital stay. Laparoscopy has become a forerunner in the pursuit of improving surgical outcomes by reducing postoperative pain and decreasing recovery time. However, the use of laparoscopic instruments can be cumbersome and unwieldy, thereby increasing operative time and reducing dexterity, which can limit the surgeon’s ability to perform the procedure with the same techniques that can be accomplished through a traditional abdominal incision. Introduced in 1999, the daVinci Surgical System, the urologists are still considered the system’s number one user, but robotic applications in gynecologic surgery have been expanding. In 2005, U.S. Food and Drug Administration approval was obtained for use of the daVinci robot (Intuitive Surgical, Inc., Sunnyvale, CA) for use in gynecologic surgery as a modification of the laparoscopic approach. This robot employs the use of robotic arms that control modified laparoscopic instruments that have seven degrees of freedom, giving the surgeon significantly improved dexterity. The advent of this technology has made it possible to perform the traditional gynecological procedures through a laparoscopic technique that allows for ease of maneuvering, thus combining the benefits of a minimally invasive surgical procedure with a shorter recovery period. The use of robotics in gynecologic surgery is increasing in the United States. A decade later, growing numbers of health-care institutions are purchasing the robotic system. In gynecology the expansion is reflected in literature reports on robotic applications in general gynecology, urogynecology/pelvic reconstructive surgery, gynecologic oncology, and reproductive endocrinology.

Robotic surgery allows a surgeon to sit at a console while three or four robotic arms move over the patient according to the surgeon’s commands. Commonly performed robot-assisted laparoscopic surgeries in gynecology include benign hysterectomy, myomectomy, tubal reanastomosis, radical hysterectomy, lymph node dissections, and sacrocolpopexies.

Indications and Contraindications for Robot-assisted Surgery:

Robot-assisted surgery has similar indications as conventional laparoscopic surgery. However, because robotic technology allows surgeons to more easily and simply perform complex laparoscopic maneuvers, the availability of the robot would allow the surgeon to perform more sophisticated procedures than the conventional laparoscopic route, therefore reducing the number of open procedures. For example, a gynecologic surgeon might ordinarily prefer an open procedure over the conventional laparoscopic route for advanced pelvic endometriosis. However, with the availability of the robotic system, which facilitates tissue dissection and suturing, the surgeon may elect the robotic approach, resulting in reduced morbidity, shorter hospitalization, less post-operative pain, earlier return to work, and better cosmetic results compared to an open operation. Contraindications, too, are usually similar to those of conventional laparoscopy (e.g., immediate need for laparotomy to control bleeding, poor visualization, or exposure). The robotic system usually shortens the operative time of a long endoscopic procedure (e.g., radical hysterectomy, lymphadenectomy, sacrocolpopexy). On the other hand, it may increase the total time of a short simple procedure (e.g., adnexectomy, endoscopic sterilization). When you add in the time spent in draping and setting up the robot, docking time, and operating room turnover time, using the robotic system in simple short endoscopic procedures may not be cost effective.

Basic Set-up and Instruments:

A basic surgical robotic system is composed of three parts: a patient-side robot, a vision cart, and the robotic master console. The robotic surgeon operates from the remote master console using a combination of hand controls and foot pedals. One foot pedal controls the camera movement (right/left, up/down, in/out) and horizontal orientation, while a nearby pedal controls the focus. Another pedal provides a clutching mechanism that allows for repositioning of hand controls and provides the instruments a range of motion beyond the physical confines of the console. Another set of pedals controls both monopolar and bipolar energy sources. The patient-side cart is wheeled in between the patient’s legs, and the robotic arms are attached to stainless steel robotic trocars through a process termed “docking”. The hand controls operate either the camera or up to two robotic instruments at one time. There are up to three operative robotic arms, with the option to swap control among any two of the three operative arms. While operating the robotic operative instruments, the surgeon is capable of manipulating, repositioning, grasping, retracting, cutting, dissecting, coagulating, and suturing. The robotic master console also provides the surgeon with three-dimensional imaging through a stereoscopic viewer.

These systems are not autonomous, and ought not to be called machines. A surgical robot is actually a collection of wristed tools called manipulators, which receive digital instructions from an interfaced computer. The surgeon, seated at an ergonomically designed video console with an “immersive” 3-D display, initiates the digital instructions by controlling sophisticated hand grips — essentially, joysticks with seven degrees of freedom, (adding the pitch, the yaw and the pincer-like movement to those that were already available). The manipulators inside the patient’s body duplicate the surgeon’s hand movements at the console, and software filters out even physiologic hand tremors (3). Despite all of these technologic advancements that make the surgeon nearly autonomous, a bedside assistant is still required for all robot-assisted cases. Their responsibility is mainly instrument exchanges, suction and irrigation, suture introduction and retrieval, and additional retraction.

Advantages of Robotic Surgery:

Robotic surgery offers three advantages over laparoscopy: a three-dimensional vision system, wristed instrumentation, and ergonomic positioning for the surgeon while performing surgical procedures. Conventional laparoscopic surgery has a steep learning curve for physicians because it has two-dimensional imaging and involves mastering counter-intuitive hand movements. Robotic surgery, however, solves some of these challenges because it uses three-dimensional imaging and instruments that move just like the surgeon’s wrist. The robotic system eliminates normal hand tremors and allows the surgeon to sit, instead of stand, during the procedure, which helps guard against fatigue. The gynecologic laparoscopic surgeon performs procedures in a confined space, the female pelvis. Wristed instrumentation allows the gynecologic surgeon to obtain the exact instrument angle available at laparotomy. This also eliminates the fulcrum effect that is present with laparoscopy, where surgeons need to move their hand in the opposite direction to the intended location of the distal instrument tip (eg, toward the patient’s left if they want the instrument moved to the patient’s right). With robotic surgery, the movements are natural, and surgeon moves their hands in whichever direction they want the instruments to move. The “wristed” instrumentation affords greater dexterity and provides seven degrees of freedom, similar to the human hand (4).

Decreased blood loss has been reported in comparative studies (5). The enhanced visualization gives the gynecologic surgeon an improved ability to identify tissue planes, blood vessels, and nerves while performing the surgical procedure. Fatigue and physical discomfort can become limitations during any surgical procedure. With robotic surgery, the surgeon sits comfortably at the surgical console from the vantage point of standing at the patient’s head and manipulates the hand controls and foot pedals while in an ergonomic position. This may serve to reduce fatigue and discomfort during complex surgical procedures. TilePro (Intuitive Surgical, Inc. Sunnyvale, CA) is a feature that allows for image and video input to the console. This can be viewed by the console surgeon for instructional purposes during the early phase of the learning curve or for input of radiologic data from ultrasonography, computed tomography (CT), or magnetic resonance imaging (MRI).

Disadvantages of Robotic Surgery:

The daVinci robot costs $ 1.65 million to purchase with annual maintenance costs of this technology is $ 149,000 per year. Minimally invasive hysterectomy approaches (vaginal and laparoscopic) are underused in the United States. For example, of hysterectomies done for the top seven non-cancer diagnoses in the United States, approximately 66.1% were abdominal, 21.8% were performed vaginally, and only 11.8% were performed laparoscopically (4)(6). Will robot surgery substantially improve outcomes over vaginal or conventional laparoscopic routes? Introduced in the early 1990s, laparoscopic-assisted vaginal hysterectomy (LAVH) was expected to replace the “blind” vaginal hysterectomy; yet in a randomized trial, the only significant difference between these surgical approaches was twice the cost to include the laparoscope. Follow-up studies did show advantages to the LAVH relative to hysterectomy done by laparotomy, yet these numbers have been stable while vaginal hysterectomy numbers have declined, presumably at the expense of LAVH. Considering these facts, many researchers believe that laparoscopic hysterectomy as it is currently practiced has contributed to no substantial improvement in patient care but has lead to increased health care costs (6)(7).

The main disadvantages of robotic surgery across applications are the cost, the large size of the robot console, limited availability within some health systems, limited tactile feedback or haptics, and the need to train residents, attending surgeons and operating room personnel on the use of this technology. Additional costs that need to be considered include the time and cost of training surgeons and operating room personnel, the potential cost or reduced productivity during a surgeon’s learning curve, and increased operative time associated with operating room setup as well as the assembly and disassembly of the robotic system during the early phase of adoption. There is evidence that with experience, operative time can become shorter with laparoscopy (5). Newer studies have actually shown cost savings of greater than $1,000 for some procedures listed below including hysterectomy. Docking time has been shown to decrease with experience. Once docked, the robotic arms are attached and fixed to specialized trocars. Because the operating table and the robot do not communicate and are therefore not synchronized, once the robotic unit is docked, the patient bed cannot be moved in any direction, including Trendelenburg; otherwise, the trocar depth can become incorrectly positioned and abdominal wall as well as visceral trauma could occur.

Vaginal cuff dehiscence with small bowel evisceration after hysterectomy is a rare event that may be occurring more frequently with the advent of robotic laparoscopic hysterectomies. Only 59 cases were reported between January 1900 and December 2001. 95% of cases performed occurred after total abdominal (TAH) or vaginal hysterectomy (TVH). Recent reviews describe a disproportionate number of vaginal cuff dehiscences occurring after total laparoscopic hysterectomy (TLH), suggesting that vaginal cuff dehiscence may be more common complication of laparoscopic hysterectomy than TAH or TVH. A retrospective review of 2,399 hysterectomies performed at the Mayo Clinic in Scottsdale, Arizona, of which 15% were performed robotically and 9% with traditional laparoscopy reported the vaginal cuff dehiscence rate to be 2.87% for robotic hysterectomy and lower for TLH, TVH, and TAH respectively. Vaginal entry technique may account for the observed increased risk of vaginal cuff dehiscence associated with robotic surgery. This observation may be because of thermal spread and cuff tissue damage from electro-surgery used for vaginal entry (8).

Applications of Robot-assisted Surgery in General Gynecologic:

Robotics has been looked upon as a possible way to facilitate the trend toward a less invasive hysterectomy and patient outcomes. The availability of the robotic system should not dictate the route of hysterectomy (endoscopic vs. vaginal). Whenever technically feasible and medically appropriate, patients requiring hysterectomy should be offered the vaginal approach because morbidity appears to be lower with vaginal approach than with any other method. Endoscopic hysterectomy is indicated in the following cases: lysis of adhesions; treatment of endometriosis; management of uterine leiomyomata, and/or adnexal masses that complicate the performance of vaginal hysterectomy; ligation of infundibulopelvic ligaments to facilitate difficult ovary removal; and evaluation of the pelvic and abdominal cavity before hysterectomy. In 2002 this study (9) reported one of the earliest experiences with robot-assisted laparoscopic hysterectomy. This series include 16 patients ranging in age from 27 to 77 years. Operative time ranged from 270 to 600 minutes, and blood loss ranged between 50 mL and 1,500 mL, with an average loss of 300 mL. The average stay was 2 days, with a range of 1 to 3 days.

The comparative study (5) to date of robotic hysterectomy to conventional laparoscopy is a retrospective review of 200 consecutive hysterectomy cases completed before and after implementation of a robotics program. There were no statistically significances in patient characteristics or uterine weights between the two groups. The rate of intraoperative conversion to laparotomy was two-fold higher in the laparoscopic cohort of 100 patients as compared with the robotic cohort (9% compared with 4%). The mean blood loss was also significantly reduced in the robotic cohort. However, the incidence of adverse events was similar in the two groups. Mayo Clinic, Scottsdale, published the largest series to date (11); ninety-one patients undergoing robotic hysterectomy were evaluated. A wide range of pathology, including ovarian neoplasms, abnormal uterine bleeding, and moderate-to-severe endometriosis, was addressed. The average uterine weight was 135.5 grams. The mean operative time was 127.8 minutes, with an estimated blood loss of only 78.6 mL and hospital stay of 1.4 days. There were no conversions to conventional laparoscopy or laparotomy and no bladder or ureteral injuries occurred.

Applications of Robot-assisted Surgery in Gynecologic Oncology:

A natural progression of robotic technology in gynecology has been to the area of oncology. Early experiences clearly demonstrated the feasibility of applying robotic assistance to laparoscopic cancer staging without an increase in complication rates or compromise to surgical technique. There were no statistically significant differences between these three approaches: laparotomy, conventional laparoscopic, and robotic, with respect to mean age, body mass index, or lymph node count (13). However, the authors did find significantly less estimated blood loss and shorter length of stay associated with the robotic approach. In this study, operative times were comparable to open surgery and better than conventional laparoscopy. There were also no conversion or intraoperative complications in the robotic group (12). Similarly Boggess et al published a study comparing robot-assisted, conventional laparoscopic and open hysterectomy with staging for endometrial cancer (14). They found the highest lymph node yields with the robotic approach. Robotic hysterectomy with staging was associated with significantly longer operative time, in this series, as compared with open hysterectomy, but shorter operative times when compared with laparoscopic group. Ultimately, 5-year survival rates will need to be evaluated to truly assess the effect of robotics on gynecologic cancer staging. Robotic surgery is a useful minimally invasive tool for the comprehensive surgical staging of the obese and morbidly obese women with endometrial cancer (12)(14). As this patient population is at increased risk of death from all causes, including post-operative complications, all efforts should be made to improve their outcomes and minimally invasive surgery provides a useful platform by which this may occur.

Applications of Robot-assisted Surgery in Reproductive Endocrinology:

Robotic technology also facilitates the dissection of the myoma and suturing of the uterine incision. In a retrospective case-matched study comparing robotic myomectomy to open myomectomy, investigators reported longer operative times in the robotic group, but decreased blood loss, and shorter length of stay when compared with the laparotomy group (15). Because various steps of myomectomy can be difficult with conventional laparoscopy, many concerns exist. In particular, the ability to enucleate leiomyomas and perform a multilayer closure requires advanced laparoscopic skills. Although pregnancy rates after myomectomy managed endoscopically are similar to those after laparotomy, a major worry continues to be the risk of uterine rupture. Also, the risk of recurrence seems to be higher after laparoscopic myomectomy compared with laparotomy. These factors and the associated learning curve may contribute to the fact that abdominal myomectomy remains the standard approach (16).

The advanced vision system along with microsurgical precision of articulating endoscopic instruments is exemplified in gynecologic surgery with tubal reanastomosis. In 2007, Dharia et al (4)prospectively compared robotic-assisted tubal anastomosis to open microsurgical tubal anastomosis in women with history of bilateral tubal ligation who desired reversal. They found robotic tubal anastomosis was associated with significantly longer operative time (201 minutes compared with 155 minutes with open) but significantly shorter hospital length of stay (4 hours compared with 34.7 hours with open) and faster return to normal activities of daily living (11.1 days compared with 28.1 days with open). Pregnancy rates were comparable between groups (62.5% compared with 50% with open), yet the robotic group had a higher number of ectopic pregnancies (4 compared to 1 with open). The cost per delivery was similar between robotic anastomosis ($92,488) and open tubal anastomosis ($92,206).

Sacrocolpopexy is probably the fastest growing reconstructive procedure performed robotically. The procedure involves extensive dissection of presacral space and rectovaginal septum, mesh positioning, suturing, and and knot tying, which is simplified by the robotic system. There are four main studies on robotic sacrocolpopexy. The major strength of this study (17) is the fact that authors report on outcomes of robotic sacrocolpopexy in comparison with a group of patients who underwent abdominal sacrocolpopexy, the gold standard for advanced vaginal vault prolapse. It is critical to include a control group for comparison to assess the efficacy of this newer minimally invasive surgical technique. It is worth noting that the abdominal group in this study comprised patients at the same institution, exposed to the same practice patterns regarding perioperative care, including similar surgical technique, antibiotic prophylaxis, and postoperative discharge guidelines as the robotic group. Another strength of this study is the use of prolapse scores. Robotic sacrocolpopexy demonstrated similar short-term vaginal vault support compared with abdominal sacrocolpopexy, with less blood loss and shorter length of stay. Operative time was longer but may decrease as the learning curve for this new procedure improves. There were similar outcomes between the two groups in terms of perioperative complications, but this is limited by the low incidence of these complications. Long-term data are needed to assess the durability of this newer minimally invasive approach to prolapse repair. Robotic vesicovaginal and ureterovaginal fistula repair has been reported through small case series and case reports. In a case series of seven patients with vesicovaginal fistula, the researchers reported an average operative time of 141 minutes (range 110 to 160). Mean blood loss was 90 mL, and no significant intraoperative or postoperative complications were observed (18).

Learning Curve and Credentialing:

The belief is that robotic surgery will allow for a more rapid development of the necessary skills and allow for a larger number of surgeons to attain those skills, and therefore, provide minimally invasive surgical options to a larger number of patients. There is a paucity of experienced robotic surgeons. Currently, the training involves practice with the surgical robot in either a pig or human fresh tissue environment to become familiar with the functions of the robot, the attachment of the robotic arms to the robotic trocars, and the overall functions of the robotic console. Further training allows surgeon to learn how to perform simple maneuvers such as grasping, cutting, and intracorporeal knot tying, the last task being particularly difficult with conventional laparoscopy. Two studies have specifically looked at learning curves. A recent study (19)evaluated 113 sequential patients over a 22-month period. They found that the learning curve for various benign surgical interventions stabilized in regard to operative time times after 50 cases. A similar learning curve was documented for the operating room team to be able to set up the robot for surgery in 30 minutes. This break point was 20 cases. A major hurdle often encountered early in a surgeon’s robotic experience is “docking time”, or the attachment of the robotic device to the patient.

With the introduction of robotic surgery, hospitals and departments have been challenged to establish credentialing requirements for this advanced surgical technique. There are no universally established credentialing guidelines. Most healthcare facilities require performing a minimum of two robotic surgical procedures of each type for which privileges are being requested in the presence of an expert preceptor. Some institutions are using four as the minimum number of proctored robotic surgeries necessary for independent robotic privileges. An expert preceptor is defined as a surgeon who has current Robotic Surgical Privileges and has been approved as an expert preceptor by the Chair of the Department of the individual applying for privileges. Similar to other surgical procedures maintenance of competence requires performing procedures on an ongoing basis.

Future of Robotic Surgery:

In this high-tech future, surgery could be performed skillfully and promptly even in dangerous or inaccessible places. In addition to small or narrow places in the human body, remote places in the world are often mentioned by those invoking the promise of robotic surgery. The logical extension of this mode of operation — telesurgery might be a good way to distribute health care in the developing countries. And NASA is exploring its potential for the proposed manned mission to the Moon and to Mars. Many of the disadvantages could be improved with further development and technologic refinement. Future research is imperative to address the questions of cost-effectiveness, effect on resident training, and whether this technology is best made available to all surgeons or to a limited number of surgeons with high surgical volume who develop particular robotic expertise and are able to maintain proficiency with this evolving technology.

Telestration, the ability to write on a touch screen and have the markings visible at the console, is helpful but does not replace the educational guidance a “co-sugeon” training robotic console would afford. Such a “co-pilot” console is currently commercialy available with Si platform. Even as the current systems begin to be put in practice, the true visionaries are focusing on the surgical robot less as a mechanical device than as an information system — one that should be fused with other information systems. One proposed example of this kind of fusion is image-guided surgery, also called surgical navigation. Robot-assisted surgeons will be able to see real-time, three-dimensional scanner images electronically superimposed over the operative field that is displayed on the monitor (20). In other words, on the screen, human anatomy will be rendered translucent, and the surgeon will be able to determine the exact location of a tumor and more readily avoid damaging vital structures — such as the major vessels and bile ducts that are sometimes accidentally severed. In fact, with preoperative scanner images, surgeons could robotically practice their patients’ surgery the night before, and the robot’s computer could be programmed not to allow its instruments to penetrate the vena cava, thereby eliminating bloody intraoperative mishaps.

In gynecologic surgery, power morcellation is sometimes used during hysterectomy and myomectomy (fibroid tumor removal) to facilitate the removal of the uterus, fibroids (leiomyomas) and/or fallopian tubes and ovaries. It is a well-established as a minimally invasive surgical technique that reduces risk of intraoperative and postoperative morbidity and mortality. Without power morcellation, some patients may be ineligible for minimally invasive surgery and would be only eligible for an abdominal incision which carries higher risks of infection, bleeding, hernia formation and other morbidities. Mortality occurs at 3x the rate in open gynecologic surgery as with minimally invasive techniques. Power morcellation continues to be an option for some patients when performing hysterectomy or myomectomy. At the same time, it is critical to minimize the risks for patients undergoing these surgeries who may have occult gynecologic cancer.

Power morcellators use rapidly rotating blades or electrical energy within a tube, through which tissue is extracted. During morcellation, small fragments of tissue may be inadvertently disseminated

Power morcellation has come under recent scrutiny because of concern about the risk of intraperitoneal dissemination of malignant tissue, particularly uterine sarcoma. Various sources cite estimates of occult sarcomas from 2:1,000 to 1:350 cases. The overall incidence of uterine sarcomas is 0.64 per 100,000 women. With morcellation and dissemination, the 5 year survival rate is 15%; even without morcellation, a diagnosis of uterine sarcoma has a poor 5 year survival rate of 40%.

As with all procedures, a thorough patient evaluation is crucial and may include appropriate measures to diagnose a malignancy before surgery. Tests may include cervical cytology, endometrial sampling, and pelvic imaging. Other preoperative considerations may include age >35 years, menopausal status, uterine size, rapid uterine growth, or certain treatments or hereditary conditions. Although preoperative evaluation may improve detection of cancer, it has limitations and does not eliminate the possibility of an occult cancer, particularly sarcomas, if sarcoma is suspected or there is a known malignancy, power morcellation should not be used. Even screening for cervical or endometrial cancers may not be 100% detectable with morcellation.

Alternative treatment options to power morcellation may include manual extra peritoneal tissue morcellation which has been safely practiced for decades during both vaginal and open or mini-laparotomy cases and no definitive studies have shown dissemination of malignant tissue intraperitoneally. Although bags are in development to reduce dissemination risk during power morcellation, they have their limitations.

All inpatient surgical procedures are performed at St. Luke’s Hospital or St. VincentMedicalCenter unless your insurance requires you go elsewhere.A surgical consent must be signed in the office prior to having your procedure scheduled.

You may stay in hospital for 1 night or longer.Or, you may go home the same day.The length of stay depends on the nature of your surgery.You will have an intravenous line to provide fluids, and a urinary catheter to drain your bladder.Drains may be present to help drain fluid from your incision.Medication to relieve pain and nausea will be available throughout your hospital stay.

After surgery, give yourself a chance to adjust and recover.Some women feel fine within a month.Many need a little extra time.Morcellation can have both physical and emotional effects that may be brief or long term.After morcellation, periods will stop with hysterectomy and reduce with myomectomy.A depressive emotional reaction to loss of the uterus, and remorse about permanent sterility is not uncommon or abnormal.Please discuss any concerns with your health care provider if persistent.Sexual response may change after hysterectomy.If pain and bleeding have been a problem, you may feel better and have more energy as your body heals.Once you have fully recovered, you can focus on enjoying your life.

Product:Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

Purpose:When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

Summary of Problem and Scope:Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.

Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.

Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.Recommendations for Health Care Providers:

Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.

Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.

Carefully consider all the available treatment options for women with symptomatic uterine fibroids.

Thoroughly discuss the benefits and risks of all treatments with patients.

For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option:

Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.

Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

Recommendations for Women:

Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.

If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.

If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.

FDA Actions:The FDA is concerned about women undergoing laparoscopic power morcellation for the treatment of uterine fibroids and the risk of inadvertent spread of unsuspected cancer to the abdominal and pelvic cavities. In an effort to enhance understanding of the problem and provide information on the appropriate use of laparoscopic power morcellators, the FDA:

Instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and providers;

Will convene a public meeting of the Obstetrics and Gynecological Medical

Device Advisory Committee to discuss: 1) the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids, 2) whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices, and 3) whether a “boxed warning” related to the risk of cancer spread should be required for laparoscopic power morcellators;

Reporting Problems to the FDA:Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a morcellator and/or specimen bag has malfunctioned or contributed to a serious injury or adverse outcome, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Vaginal Mesh Complication Surgeons | Mesh Surgery

Over the past decade, the use of mesh for treatment of pelvic organ prolapse and urinary incontinence has become increasingly common secondary to trying to improve cure rates in patients who have weak native tissue where a native repair would fail. Many different companies have produced different materials and methods for gynecologic placement of mesh. Some of those products utilized show higher complication rates versus others. Type I macroporous, polypropylene mesh has been shown to be the best tolerated material to date due to its softness, porousity and tendency to assimilate to the body well. Howevever, unfortunately, complications can still occur with the best meshes under optimal surgical conditions with the best surgeons secondary to the permanent nature of the material.

Mesh has a proper indication for certain gynecolgic patient conditions and when placed by experienced surgeons, outcomes have been statistically shown to be excellent. Dr. Croak agrees with this statement and uses mesh for stress urinary incontinence (SUI) and abdominal pelvic organ prolapse (POP) repair when appropriately indicated. He takes the time to explain the pros and cons of mesh when needed.

Patients that suffer from surgical mesh complications may find difficulty in receiving adequate treatment as many surgeons are not trained to handle these problems or choose not to do so because of threat of litigation. Dr.Croak has extensive experience in the proper use of mesh and the treatment of complications when they do occur. He has removed or revised over 300 mesh complication in the past several years.

Complications that are known to occur requiring potential surgical treatment include:

Failure of the Procedure

Pain (Vagina, leg, pelvic, adbominal, sexual)

Infection or rejection of the graft material

Recurrence of prolapse and incontinence with mesh

Recurrent urinary tract infection

Extrusion of the mesh into the vagina causing pain, discharge, bleeding

Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.

Background: A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity. Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

Talking to your doctor: Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene. Questions you should ask the surgeon before you agree to surgery in which mesh will be used:

What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?

If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?

What’s been your experience in dealing with the complications that might occur?

What can I expect to feel after surgery and for how long?

Are there any specific side effects I should let you know about after the surgery?

What if the mesh doesn’t correct my problem?

If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?

If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Reporting complications to the FDA: In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.

You can report any problems to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or FAX.

In 2008, the FDA put out a safety communication regarding vaginally placed mesh for pelvic organ prolapse (POP) regarding complications reported over the recent past few years. The notification and its 2011 update detailed that the FDA has received over 1,500 reports of complications during the past several years (out of approximately 250,000 vaginal mesh procedures completed) regarding vaginally placed mesh for prolapse or incontinence. Adverse events included erosion, pain, infection, bleeding, pain with intercourse, organ perforation during the surgery and urinary and/or bowel problems. Many complications potentially require further surgery or treatment and may not resolve completely. The increase in complications reported was due to more mesh surgery being performed. The communication pertained primarily to vaginal mesh placement for treatment of POP. The FDA mandated a recall in 2012 of any of the vaginally placed POP mesh products, particularly the “kits.” Companies producing vaginal mesh kits for POP did start to remove these products from the market as early as 2012.

In 2014, the FDA propsed a reclassification of vaginally placed meshes from a mild to moderate risk class II device (FDA example given of a condom) to a class III device that carries significant risk and requires pre and post market surveillance along with substantial scruntiny of performace and complications (FDA example given of a heart valve).

Although risks including but not limited to erosion, pain, and scar tissue are all risks of mesh placed abdominally for POP or vaginally for SUI, the FDA excluded sacrocolpoxies and incontinence slings from the notification as it seems that not as many complications have been reported with these procedures and there are extensive studies supporting the mesh use for these procedures, thus qualifying them as the current “gold standard” for POP and SUI surgical treatment. The use of mesh abdominally or laparoscopically (i.e. sacralcolpopexy) POP and the mesh used in slings for SUI was effectively EXCLUDED and EXHONORATED by the FDA; therefore these specific meshes were not reclassified as a high risk device.

Although there are many published studies including hundreds of patients that show excellent results with minimal complications when mesh is placed vaginally for prolapse, newer conclusions have been made that most cases of prolapse do not need mesh for successful treatment therefore eliminating the risk of mesh. If mesh is to be used at all for vaginal POP repair, risks/benefits/alternatives should be extensively reviewed with the patient and all other treatment options should be exhausted. The surgeon must ensure he/she has the proper training to correctly select patients with indications for mesh, to place vaginal mesh, and to take care of any complications that may occur.

It is important to note that NO surgery is risk free. Prolapse and incontinence surgery without mesh may be extremely complex and thus, carries similar risks of mesh augmented surgery. In many cases, non-meshed surgery carries extra risk of failure.

Therefore, this implies that it is NOT the mesh that is the problem in every instance. The problem may lie in how mesh is placed and in whom. Whether mesh is used or not, prolapse and incontinence surgery is advanced surgery and extra training and expertise is critical to obtaining good outcomes in patients.

Up until 2012, many companies marketed mesh “kits” for POP and SUI surgery as providing a “minimally invasive surgery” that “anyone” can learn. These companies trained many new surgeons on their use, most of whom have had minimal training in pelvic floor reconstruction. Altruistically, these surgeons had the goal of truly helping their patients with a very frustrating problem or recurrent prolapse or incontinence- they were looking for a better tool. Consequently, from 2002-2012, there was a great increase in these type of surgeries being performed and in many cases by non-specialists. Unfortunately, just because the procedure is in a “kit,” it does not make ithe procedure simple for everyone to perform. Most of the complications reported are in regards with these “kit” surgeries. Despite modifications and improvements to some of these kits, issues complications still arose. It does seem to be very clear that many of the complications reported can be minimized tremendously by proper surgeon experience and training. However, risks of surgery will FDA approved or recalled mesh will always be present. The FDA, the American Urogynecologic Society (AUGS), the Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the American Association of Gynecologic Laparoscopists have all resleased official position statements supporting FDA approved mesh usage and all have recommended improved training, credentialing and monitoring by hospitals on who should be completing these procedures, which will help decrease complications.

Dr. Croak supports mesh use in POP and SUI surgery for the right patient. He has used it for many years in his practice with excellent outcomes and has reported his results in the peer reviewed medical journals. Dr. Croak will continue to use mesh when indicated, while appropriately providing informed consent of potential risks of mesh as well as alternatives such as biologic grafts. Without using augmentative materials, Dr. Croak would not get high cure rates when compared to “traditional” surgery without mesh in people with poor tissue strength. He supports the FDA notification entirely. The Northwest Ohio Center for Urogynecology and Women’s Health wishes to make themselves readily available to their colleagues and patients to assist with any issues or concerns regarding mesh complications. Many complications are small extrusions and may be simply handled if they are addressed early and appropriately!

If litigation, either class-action or directed, is being considered by the patient, it is imperative that they inform Dr. Croak of this consideration.

He is sympathetic to every patients’ situation but will need to review the case individually, and does reserve the right to decline acceptance of care. Please understand that Dr. Croak needs to do his job as a physician and keep his priorities on his office and hospital practice first and foremost. By taking on mesh complication cases out of his willingness to help those with problems, he unfortunately has been forced to delegate an ever increasingly disproportionate amount of time towards subsequent litigatory efforts. This is not why Dr. Croak became a physician. It is with great reluctance, that as litigation regarding mesh complications has increased, Dr. Croak has begun to limit the cases he will see because of this burden to his practice. To put this sensitive point in perspective, several of the best and largest academic medical centers in the country have recently instituted policies of refusing to even see mesh complications if their surgeons did not perform the original surgery.

Please be expected to sign a waiver relinquishing Dr. Croak from any and all risk of litigation if you wish to have him assist you with your situation.